Intracerebral Haemorrhage (ICH)ESProNCT07771335
The Erlanger Stroke Registry (ESPro) is the Only Ongoing Prospective Population-based Stroke Registry in Germany, Started in 1994. ESPro Includes All Hospitalized and Non-hospitalized Patients With Stroke in the Community of Erlangen (120.000 Inhabitants), With a Long-life Follow-up.
An observational study of Intracerebral Haemorrhage (ICH) and Cerebral Infarction, run by University of Erlangen-Nürnberg Medical School at 3 sites in Germany.
Trial summary
Stroke is a disease that primarily affects older adults and, with an estimated 64,000 deaths in 2024, is one of the leading causes of death in Germany. Estimates of its prevalence and the burden of disease within the German population are therefore essential for calculating future healthcare needs and guide health… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Haemorrhage (ICH), Cerebral Infarction, Cerebral Infarction Due to Thrombosis of Cerebral Arteries
- How many people
- 17,000 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Apr 1994to 30 Mar 2094
- How long will I take part?
- 30 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Erlangen Stroke Project (ESPro) is a community-based survey of all cases of stroke occurring in a university town, located in Bavaria in Southeast Germany. Several overlapping sources of information were used to ensure complete case ascertainment: (1) hospital admission and discharge lists and computer-linked records systems; (2) regular checks of all relevant hospital wards and residential and nursing homes; (3) records of ambulance and emergency services; (4) GPs; and (5) death certificates.
Who may be able to join
- All cases of stroke defined according to WHO criteria, as "rapidly developing clinical symptoms and/or signs of focal, and at times global, loss of cerebral function, with symptoms lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin occurring in Erlangen, Bavaria
- No restrictions regarding age (provided they are of legal age), socioeconomic circumstance, stroke severity, or prior health status
Who cannot join
- Patients with transient episodes lasting less than 24 hours and those with asymptomatic lesions detected by brain imaging ("silent infarcts")
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med. contact
Germany3 sites, 3 recruiting
- Recruiting
Malteser Waldkrankenhaus St. Marien
Erlangen, 91054
- Recruiting
Universitätsklinikum Erlangen
Erlangen, 91054
- Recruiting
Klinikum am Europakanal
Erlangen, 91056
About this study
Official title: The Erlangen Stroke Registry (ESPro)
Stroke is a disease that primarily affects older adults and, with an estimated 64,000 deaths in 2024, is one of the leading causes of death in Germany. Estimates of its prevalence and the burden of disease within the German population are therefore essential for calculating future healthcare needs and guide health policy planning. When the first stroke units (SU) began to emerge in Germany in 1994, health insurers raised the question of the total number of stroke patients requiring care. Unfortunately, at that time there were no reliable figures available to determine the nationwide need for stroke units. This marked the birth of the Erlangen Stroke Registry (ESPro).
For 32 years (1994-2026), ESPro has been continuously collecting data on the epidemiology, clinical course, and care of stroke and dementia, two of the most common diseases. The ESPro is designed as a regional, population-based registry that includes, as far as possible, all diagnosed strokes-that is, both hospitalized and non-hospitalized patients-regardless of age group or severity of the condition. Patients enrolled in the city of Erlangen undergo close monitoring of their clinical course and are followed up at intervals of 3 and 12 months, and then annually for the rest of their lives. This long-term follow-up enables comprehensive health services research on stroke, a widespread disease. Direct information on the course of the disease, its treatment, and care can be gleaned from registry data and incorporated into preventive medicine, treatment, and care planning.
- Conditions
- Intracerebral Haemorrhage (ICH), Cerebral Infarction, Cerebral Infarction Due to Thrombosis of Cerebral Arteries, Cerebral Infarction Due to Embolism of Cerebral Arteries, Stroke, Not Specified as Haemorrhage or Infarction, Transient Cerebral Ischaemic Attacks and Related Syndromes
- Keywords
- Stroke, Erlangen, Germany, Registry
- Medical subject headings
- Cerebral Hemorrhage, Cerebral Infarction, Stroke, Dementia, Vascular, Dementia, Multi-Infarct, Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with stroke | All individuals diagnosed with stroke (both hospitalized and non-hospitalized) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Name
Measured: Baseline
Address
Measured: Baseline
Postal code
Measured: Baseline
Telephone number
Measured: Baseline
Gender
Measured: Baseline
Date of birth
as date
Measured: Baseline
Date of death
as date
Measured: After 3 months, after 12 months, then annually until the event occurs. Currently there is a follow-up of 32 years-up
Nationality
Measured: Baseline
Education
Measured: Baseline
Employment status
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Marital status
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Number of children
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Name of the health insurance company
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Length of residence in the study area
Measured: Baseline
Living arrangements
Which kind of living arrangement (own home environment, assisted living, nursing home) and who are the people, who live in this arrangement (alone, spouse, children, relatives, others)
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Telephone number of the General practitioner
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Assistance
yes/ no
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Name of the contact person
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Telephone number of the contact person
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Relationship between the patient and the contact person
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
National Institutes of Health Stroke Scale (NIHSS)
Total Score Range: 0-42 (15 items, each scored on 3-5 point ordinal grades, 0 = normal), higher values indicate greater stroke severity (0 = no stroke symptoms, 1-4 minor, 5-15 moderate, 16-20 moderate-to-severe, 21-42 severe)
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
(Modified) Rankin Scale
Total Score Range: 0-6 (7-point ordinal disability scale), higher values indicate worse (higher) disability (0 = no symptoms, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, 6 = death)
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Mini-Mental State Examination (MMSE)
Total Score Range: 0-30, higher values indicate better cognitive performance
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Medication
Name of the drug
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Medication
Quantity
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Medication
Dose in milligrams per day
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Charlson Comorbidity Index (CCI)
Total Score Range: 0-33, higher values indicate a worse (greater) comorbid disease burden
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Hypertension
yes/ no
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Diabetes mellitus
yes/ no
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Hypercholesterinemia
yes/ no
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
TOAST-Classification
Categorical etiologic classification system; it sorts ischemic stroke into 5 mutually exclusive subtype categories: (1) large-artery atherosclerosis, (2) cardioembolism, (3) small-vessel occlusion (lacunar), (4) stroke of other determined etiology, and (5) stroke of undetermined etiology
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Medical Outcomes Study Social Support Survey (MOS-SSS)
Total Score Range: Raw sum score: 19-95 (19 items, each rated on the 5-point frequency scale: 1 = none of the time … 5 = all of the time), Transformed index (0-100 scale), higher values indicate better (greater) perceived/available social support
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Short Form 36 Health Survey (SF-36)
Physical health and mental health summary scores, Total Score Range: 0-100, norm-based scoring, higher values indicate a better physical/mental health status
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Barthel Index
Total Score Range: 0-100, higher values indicate better functional independence (less disability)
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Frenchay Activities Index (FAI)
Total Score Range: 15-60, higher values indicate better (greater) frequency/independence in instrumental activities of daily living (IADL)
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Functional Independence Measure (FIM)
Total Score Range: 18-126, Subscales: FIM-motor 13-91, FIM-cognitive 5-35, higher values indicate better (greater) functional independence (18 = total dependence, 126 = total independence)
Measured: Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Apr 1994
- Primary completion30 Mar 2094 (estimated)
- Study completion30 Mar 2094 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral Haemorrhage (ICH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771335
- Sponsor's protocol ID
- 249_15 Bc
- Other IDs
- ZMV I 1-2520KEU305, DRKS00040516
- Acronym
- ESPro
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information on the use of research data from the Erlangen Stroke Registry can be found on the website at the following link: https://www.izph.fau.de/projekte/erlanger-schlaganfallregister/#angebot-zur-nutzung-von-forschungsdaten-aus-dem-erlanger-schlaganfallregister